Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 8
- 主要终点
- Distance Visual Acuity (VA) (Part A)
研究概览
简要总结
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
详细描述
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.
Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Part A is double masked. Part B is single masked (trial subject).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an approved Informed Consent Form.
- •Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- •Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
- •History of refractive surgery or plan to have refractive surgery during the study.
- •Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- •Routinely sleeps in contact lenses at least 1 night per week.
- •Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
- •Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Distance Visual Acuity (VA) (Part A)
时间窗: Day 30, each study lens type
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
次要结局
未报告次要终点